Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company
Form 483 issued February 13, 2026 · Manati, Puerto Rico
- Inspection
- Jan 12 – Feb 13, 2026
- Investigators
- Angelica M. Hernandez· Santos E. Camara
- Observations
- 3
- Pages
- 8
- FEI number
- 2650089
In short: On February 13, 2026, FDA issued a Form 483 with 3 observations to Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company in Manati, Puerto Rico (FEI 2650089) after an inspection that ran Jan 12 – Feb 13, 2026. The investigators were Angelica M. Hernandez and Santos E. Camara. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and laboratory controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
The reserve sample of drug product does not consist of at least twice the quantity necessary…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
This inspection in context
Angelica M. Hernandez
15 documents · 2022–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmBristol-Myers Squibb Holdings Pharma Ltd. Liability Company history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company?
FDA listed 3 observations on this Form 483, mostly about quality system, laboratory controls and production. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company?
Angelica M. Hernandez and Santos E. Camara are named on this Form 483, for the inspection of Jan 12 – Feb 13, 2026. Each investigator has a profile showing what they cite most.
When was Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company inspected by FDA?
The inspection ran Jan 12 – Feb 13, 2026, and the Form 483 is dated February 13, 2026.
How do I get the full Form 483 for Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.